30 mg & 60 mg & 90 mg film-coated tablets
cinacalcet
What Cinacalcet STADA is and what it is used for
Cinacalcet Stada is used to control the levels of parathyroid hormone (PTH), calcium, and phosphorus in the body. It is used to treat problems in the organ called the parathyroid gland. The parathyroid gland consists of four small glands in the throat near the thyroid gland and produces a parathyroid hormone (PTH).
This medicine is used in adults to:
- treat secondary hyperparathyroidism in patients with severe kidney disease who need dialysis to cleanse the blood of waste products.
- reduce high levels of calcium in the blood (hypercalcemia) in patients with thyroid cancer.
- reduce high levels of calcium in the blood (hypercalcemia) in patients with primary hyperparathyroidism when the parathyroid gland cannot be removed.
Cinacalcet is used in children from 3 years up to 18 years to:
- treat secondary hyperparathyroidism in patients with severe kidney disease who need dialysis to cleanse the blood of waste products and whose disease cannot be kept under control with other treatments.
In primary and secondary hyperparathyroidism, too much PTH is produced by the parathyroid gland. “Primary” means that hyperparathyroidism is not caused by another disease and “secondary” means that hyperparathyroidism is caused by another disease, e.g. kidney disease. Both primary and secondary hyperparathyroidism can cause a decrease in skeletal calcium, which can lead to skeletal pain and fractures, heart and blood vessel problems, kidney stones, mental illness, and coma .
Cinacalcet contained in Cinacalcet Stada may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.
2. What you need to know before using Cinacalcet STADA
Do not use Cinacalcet STADA
- if you are allergic to cina calcium or any of the other ingredients of this medicine (listed in section 6)
- if you have low calcium levels in your blood. Your doctor will check your blood calcium levels.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Cinacalcet Stada.
Before you start taking this medicine, tell your doctor if you have or have ever had:
- seizures (attacks or convulsions). The risk of seizures is greater if you have had them before
- liver problem
- heart failure
Cinacalcet Stada lowers calcium levels in the blood. Life-threatening events and death due to low calcium levels (hypocalcemia) have been reported in adults and children treated with cina calcium.
Tell your doctor if you experience any of the following symptoms, which may be signs of low calcium levels: spasms, twitches or cramps in the muscles, numbness or tingling in the fingers, toes or around the mouth, or seizures, confusion or loss of consciousness while you treated with this drug.
Low calcium levels can affect heart rhythm. Tell your doctor if you have an unusually fast or fast heartbeat, if you have a heart rhythm problem, or if you are taking medicines that are known to cause heart rhythm problems, while you are being treated with this medicine.
For more information, see section 4.
When taking this medicine, tell your doctor:
- if you start or stop smoking, as it may affect the way Cinacalcet Stada works.
Children and young people
Children under 18 years of age with parathyroid cancer or primary hyperparathyroidism should not take Cinacalcet Stada.
If you are being treated for secondary hyperparathyroidism, your doctor should check your calcium levels before you start treatment with cina calcium and regularly during treatment with china calcium. Tell your doctor if you experience any of the signs of low calcium levels described above.
It is important that you take cinacalcetose dose in accordance with your doctor’s instructions.
Note:
For children who need a dose lower than 30 mg or who are unable to swallow tablets, other dosage strengths/medicines of cinacalcet are available.
Other medicines and Cinacalcet STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially ethyl calcium or other medicines that lower your blood calcium levels.
You should not use Cinacalcet Stada with ethyl calcite.
Tell your doctor if you are taking any of the following medicines.
Drugs such as these may affect the way Cinacalcet Stada works:
- medicines used to treat skin and fungal infections ( ketoconazole, itraconazole, and voriconazole)
- medicines used to treat bacterial infections (telithromycin, rifampicin, and ciprofloxacin )
- a drug used to treat HIV – infection, you and AIDS (ritonavir)
- a drug used to treat depression (fluvoxamine).
Cinacalcet Stada may affect the way medicines work like this:
- medicines used to treat depression (amitriptyline, desipramine, nortriptyline, and clomipramine)
- a drug used to relieve cough (dextromethorphan)
- drugs used to treat changes in heart rate ( flecainide and propafenone )
- a drug used to treat high blood pressure ( metoprolol ).
Cinacalcet STADA with food and drink
Cinacalcet Stada should be taken with or after a meal.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Cinacalcet Stada has not been tested in pregnant women. If you become pregnant, your doctor may choose to change your medication as Cinacalcet Stada may harm the unborn baby.
It is not known whether Cinacalcet Stada is excreted in human milk. Your doctor will discuss with you whether to discontinue either breast-feeding or treatment with this medicine.
Driving and using machines
Dizziness and seizures have been reported in patients taking cina calcium. If you experience these side effects, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Cinacalcet STADA contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Cinacalcet STADA
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Your doctor will tell you how much Cinacalcet Stada to take.
Dosage
Your doctor will take regular blood tests to check your disease progression and will adjust dose one if necessary.
If you are being treated for secondary hyperparathyroidism
The recommended starting dose of this medicine is 30 mg once daily.
The recommended starting dose of cina calcium for children from 3 years up to 18 years is a maximum of 0.20 mg/kg / day.
Note:
For children who need a dose lower than 30 mg or who are unable to swallow tablets, other dosage strengths/medicines of cinacalcet are available.
If you are being treated for thyroid cancer or primary hyperparathyroidism
The recommended starting dose of this medicine for adults is 30 mg (one tablet) twice daily.
How to take the tablets
Cinacalcet Stada should be taken orally, with or after a meal. The tablets should be swallowed whole and must not be chewed, crushed, or divided.
The notch is not intended for splitting the tablet.
If you forget to use Cinacalcet STADA
Do not take a double dose to make up for a forgotten dose.
Even if you forget to take a dose of this medicine, take the next dose as usual.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if you:
- begins to feel numbness and tingling around the mouth, muscle aches or cramps, and seizures. These may be signs that your calcium levels are too low (hypocalcemia)
- swelling of the face, lips, mouth, tongue, or pharynx, which may cause difficulty swallowing and breathing ( angioedema ).
Very common (may affect more than 1 user in 10)
- nausea and vomiting. These side effects are often relatively mild and do not last long.
Common (may affect up to 1 in 10 people)
- dizziness
- numbness and tingling ( paresthesia )
- loss of ( anorexia ) or decreased appetite
- muscle pain ( myalgia )
- weakness ( asthenia )
- rash
- decreased testosterone levels
- high potassium levels in the blood ( hyperkalemia )
- allergic reactions (hypersensitivity)
- headache
- seizures
- low blood pressure ( hypotension )
- upper respiratory tract infection
- difficulty breathing ( dyspnoea )
- cough
- indigestion ( dyspepsia )
- diarrhea
- abdominal pain, abdominal pain – upper
- constipation
- muscle spasms
- back pain
- low calcium levels in the blood (hypocalcemia).
Has been reported (occurs in an unknown number of users)
- hives ( urticaria )
- swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing ( angioedema )
- unusually fast or beating heartbeat, which may be due to low calcium levels in the blood ( QT prolongation and ventricular arrhythmia, secondary to hypocalcemia).
After taking cina calcium, a very small number of patients with heart failure have experienced worsening of their condition and/or low blood pressure ( hypotension).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Cinacalcet STADA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
No special temperature instructions. Store in the original package. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance in Cinacalcet Stada is cinacalcet (as hydrochloride).
Each film-coated tablet contains 30 mg of cina calcium (as hydrochloride).
Each film-coated tablet contains 60 mg of cina calcium (as hydrochloride).
Each film-coated tablet contains 90 mg of cina calcium (as hydrochloride).
Other ingredients are
The core of the tablet
Microcrystalline cellulose, maltodextrin, crospovidone, colloidal anhydrous silica, sodium starch glycolate, magnesium stearate.
Tablet coating
Hypromellose (E464), titanium dioxide (E171), triacetin, yellow iron oxide (E172), indigo carmine (E132).
What the medicine looks like and the contents of the pack
Cinacalcet Stada 30 mg film-coated tablets are green, oval, biconvex film-coated tablets.
Cinacalcet Stada 60 mg film-coated tablets are green, oval, biconvex film-coated tablets, with an embossed line on one side.
Cinacalcet Stada 90 mg film-coated tablets are green, oval, biconvex film-coated tablets.
They are available in blister packs of PVC / PCTFE / PVC / Al.
Cinacalcet Stada film-coated tablets are available in blister packs containing:
30 mg: 28, 30, 50 and 84 film-coated tablets or 28×1, 30×1, 50×1 and 84×1 film-coated tablets (single-dose blisters).
60 mg: 28, 30 and 84 film-coated tablets or 28×1, 30×1 and 84×1 film-coated tablets (single-dose blisters).
90 mg: 28, 30 and 84 film-coated tablets or 28×1, 30×1 and 84×1 film-coated tablets (single-dose blisters).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria
Centrafarm Services BV
New Donk 9
NL- 4879 AC Etten-Leur
Netherlands
Clonmel Healthcare Ltd.
Waterford Road
Clonmel, Co. Tipperary
Ireland
Thornton & Ross Ltd.
Linthwaite, Huddersfield,
West Yorkshire HD7 5QH
UK
Local representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark